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Threshold Pharmaceuticals Inc. Message Board

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  • tredleon tredleon Feb 12, 2007 6:53 PM Flag

    Estimated Survival at 9%

    The trials referenced on the website were the trials done by Baxter prior to Glufo being purchased by THLD - the phase II trial of Glufo alone had overall median survival of 5.6 months (5.3 preliminary estimate) and estimated 2-year survival of 9%.

    How this compares to Gemzar is a little uncertain - the pivotal Tarceva trial showed the placebo group (i.e. Gemzar alone) had an overall median survival of 6.0 months and a 1-year survival of 19% - they don't give an exact 2-year survival number, but if you look at the accompanying graph, it looks like it is well below 10%.

    Note that this trial was a study of Glufo alone as a "first-line" treatment, which neither of the current trials are doing - the PIII is Glufo alone as a second-line/last ditch treatment on those who have failed first-line Gemzar therapy, so the results of that trial will not be comparable. The PII trial is Glufo in combo with Gemzar as a first-line treatment, and the best comparable to that is probably the Tarceva combo data, which is the basis for the Tarceva approval - this increased median survival from the placebo of 6.0 to 6.4, and 1-year survival from 19% to 24% (again, no clear 2-year data, but it is less than 10%).

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